I have previously posted on two non-surgical sterilization procedures, Adiana and Essure. Both have big benefits over a tubal ligation. But for Adiana it’s past tense-unfortunately, this procedure is no longer available. Why? It boils down to a law suit…
Adiana was manufactured by Hologic, and in July of 2009, it got FDA approval. But as soon as November of the same year, litigation began, with Conceptus, the manufacturer of Essure suing for patent infringement. The legal battle went on until the fall of 2011, when, after a two-week trial, according to Dawn Stacey M.Ed, LMHC, the jury found that the Adiana “directly and indirectly infringed upon certain method claims of Conceptus’ Essure patent. The actual Adiana insert was not found to violate the Essure patent, but the jury determined that the procedure for how it works was considered to infringe upon the method claims in the lawsuit.”
Conceptus was awarded $18,807,241 in damages as well as a 20% royalty rate for ongoing damages. Conceptus declined the royalty rate, “in hopes of suing for more money.”
And they did, as well as for a permanent injunction against the Adiana system. The judge in the case denied both. He also denied Hologic’s motion to overturn the jury infringement verdict and order a new trial.
So the parties were left to settle. Conceptus agreed not to take the $18.8 million in damages in return for Hologic giving the Conceptus licensing rights to its permanent contraception technology, and agreeing not to manufacture, sell or distribute the Adiana system.
By April of 2012, Hologic announced it was going to discontinue the manufacturing of Adiana in the U.S. and worldwide.
I spoke with Dr. Schwartz, the doctor I previously interviewed about the pros and cons of Adiana and Essure, about this legal battle and its outcome. “Hologic just got tired of fighting it,” he said.
Some word on the digital street describes the whole thing as Conceptus seeing Adiana as tough competition, trying to put the product out of business from the get go, and in the end, being successful in doing so.
Outcome – Now women have only option for non-surgical permanent contraception. But it is a good one – like Adiana, Essure has 99% effectiveness.
Since my initial interview, Dr. Schwartz says he still likes Adiana better – because “the Adiana device is easier to insert and better for the patient since no part of it protrudes into the uterine cavity or out into the fallopian tube,” which can create post-procedure discomfort.
He bought as many Adiana systems as he could once he learned of the outcome of the lawsuit (docs could order them until May of this year, and those already manufactured and for sale could still be sold until the supply runs out.)
So if you are interested in seeking Adiana, it may not be too late. You still may be able to find a doctor who has Adiana and can do the procedure.
Dr. Stacey has indicated that “even though Conceptus now has these licensing rights, the company has no intention of promoting or selling the Adiana system.” Too bad.
Bottom line, if you are seeking permanent birth control or sterilization, Essure remains a worthy – and only – alternative to tubal ligation.
Others know scuttle on this litigation? Had Essure or Adiana done? Your experience?